A randomized controlled trial of the effect of a pharmaceutical care program on improving adherence to statin therapy: The statin intervention research project (STIPT)

Background: Despite the well-known beneficial effects of statins, many patients do not adhere to chronic medication regimens. Objectives: To assess the efficacy of a pharmaceutical care (PC) program developed to improve patients' adherence. Methods: New users of statins were randomly assigned to receive usual care (UC) or a pharmacist intervention. The intervention consisted of five individual counseling sessions by a pharmacist during a 1-year period. During these sessions, patients received structured education about the importance of medication adherence, lipid levels were measured and the association between adherence and lipid levels was discussed. Adherence to statin therapy was assessed as Abstract of the 26th ICPE 2010 S35 time to discontinuation of treatment and drug-taking compliance (percentage of prescribed drugs actually dispensed). Results: A total of 899 subjects (439 in the PC and 460 in the UC group) were evaluable for efficacy by intention-totreat (ITT), and 853 (393 in the PC and 460 in the UC group) for per-protocol (PP) analysis. The PC program resulted in a significant lower rate of discontinuation within six months after initiating therapy (ITT: HR 0.66, 95% CI: 0.46-0.96; PP: HR 0.53, 95% CI: 0.36-0.80). Twelve months after initiating therapy, this difference in discontinuation rate was only significant in the PP analysis (ITT: HR 0.84, 95% CI: 0.65-1.10; PP: HR 0.73, 95% CI: 0.55-0.97). Drug-taking compliance was very high (>99%) in both the PC and UC group and did not differ between groups. Conclusions: We demonstrated the feasibility and efficacy of a community pharmacy-based PC program to improve medication adherence in new users of statins.